Search by Drug Name or NDC

NDC 36800-0052-60 TopCare 10 mg/g Details

TopCare 10 mg/g

TopCare is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is TOLNAFTATE.

MedlinePlus Drug Summary

Tolnaftate stops the growth of fungi that cause skin infections, including athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 36800-0052-60
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tolnaftate

Product Information

NDC	36800-0052
Product ID	36800-052_cbbdbcd1-b4ad-4e7c-a90e-f71d56cade04
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	TopCare
Proprietary Name Suffix	Tolnaftate Antifungal
Non-Proprietary Name	Tolnaftate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	TOLNAFTATE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0052-60 (36800005260)

Pricing Information	N/A
NDC Package Code	36800-052-60
Billing NDC	36800005260
Package	1 TUBE in 1 CARTON (36800-052-60) / 14.2 g in 1 TUBE
Marketing Start Date	2006-02-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aba4ce9a-ae88-4223-b20f-d7897f7c2232 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

cures most athlete's foot, jock itch, and ringworm
relieves itching, burning, cracking, scaling, redness, soreness, irritation and discomfort

Warnings

Do not use on children under 2 years of age unless directed by a doctor.

For external use only.

Avoid contact with eyes.

Stop use and ask a doctor if

irritation occurs
there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch

If pregnant of breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

wash affected area and dry thoroughly
apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
supervise children in the use of this product
for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
if condition persists longer, consult a doctor
this product is not effective on the scalp or nails

Other information

store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

Questions or comments?

866-323-0107 or www.natureplex.com

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

NDC 36800-052-60

TopCare

health™

PRESCRIPTION STRENGTH

Athlete's Foot Cream

TOLNAFTATE CREAM 1% • ANTIFUNGAL

• OUR PHARMACISTS •

RECOMMEND

NET WT 0.5 OZ (14 g)

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

INGREDIENTS AND APPEARANCE

TOPCARE TOLNAFTATE ANTIFUNGAL

tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-052
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV)	Tolnaftate	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Polyethylene glycol 400 (UNII: B697894SGQ)
Polyethylene glycol 3350 (UNII: G2M7P15E5P)
titanium dioxide (UNII: 15FIX9V2JP)
petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-052-60	1 in 1 CARTON	02/17/2006
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333C	02/17/2006

Labeler - Topco Associates LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(36800-052)

Revised: 12/2020

Document Id: cbbdbcd1-b4ad-4e7c-a90e-f71d56cade04

Set id: aba4ce9a-ae88-4223-b20f-d7897f7c2232

Version: 4

Effective Time: 20201202

Search by Drug Name or NDC

NDC 36800-0052-60 TopCare 10 mg/g Details

TopCare 10 mg/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 36800-0052-60 (36800005260)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL aba4ce9a-ae88-4223-b20f-d7897f7c2232 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?